New drug duo shows promise against tough head and neck cancer

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Evaluable tumor burden assessed by H\&N-computed tomography scan (CT-scan) or magnetic resonance imaging (MRI), based on RECIST v 1.1 * Patients eligible to cisplatin-based chemotherapy * No hearing loss by clinical assessment or ≤ grade 2 hearing impairment (according to NCICTCAE v.5 * No prior treatment with chemotherapy, immunotherapy and targeted therapy for H\&N cancer, radiotherapy or surgery in the head and neck region. Exclusion Criteria: * Metastatic disease (stage IVC as per AJCC/TNM, 8th Ed.). * Patients having received prior therapy with anti-PD1, anti-PD-L1, anti-PD-L2, anti- CD137, or anti-CTLA-4 antibody (or any other antibody or drug specifically targeting Tcell co-stimulation or checkpoint pathways). * Treatment for other diseases with an investigational agent or use of an investigational device within 4 weeks of the first dose of study treatment * History of another malignancy within the last 3 years prior to randomization, with the exception of completely resected non-melanoma cell skin cancer outside the head and neck area or completely resected stage I breast cancer, or completely resected in-situ nonmuscular invasive bladder, cervix, uterine and/or prostate (Gleason 6) carcinomas, or T1a squamous cell carcinoma of the esophagus or rectum/anus. * Patients with clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke (\< 6 months prior to enrollment), myocardial infarction (\< 6 months prior to enrollment), unstable angina, congestive heart failure (≥ New York Heart Association Classification Class II), or serious cardiac arrhythmia requiring medication, or known persistent reduced left ventricular ejection fraction \< 50%. * Patients with positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS). * Patients with positive tests for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus ribonucleic acid (HCV RNA) indicating active or chronic infection. Presence of other serious liver diseases, including chronic autoimmune hepatic disorders, primary biliary cirrhosis or sclerosing cholangitis.